an open-label, single-arm clinical study of stapokibart injection in combination with tislelizumab injection in patients with non-small cell lung cancer

Conditions: Lung Cancer (NSCLC)

Summary: this is a single-arm study evaluating the efficacy and safety of stapokibart injection in combination with tislelizumab injection in patients with driver gene-negative nsclc who have failed prior pd-1/pd-l1 inhibitor therapy.


Eligibility criteria:
inclusion criteria: * capable of comprehending the nature of the study and voluntarily signing the informed consent form (icf). * aged ≥18 and ≤75 years, regardless of gender. * patients with driver gene-negative nsclc who have failed first-line standard therapy and are ineligible for second-line therapy or alternative chemotherapy regimens. * treatment failure definition: disease progression during or after treatment. changes in therapy due to drug intolerance are not considered treatment failure. * at least one measurable tumor lesion per recist v1.1. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * investigator-assessed life expectancy ≥3 months. * agreement to undergo tumor tissue biopsy prior to initial study treatment and during therapy when clinically feasible. * adequate organ function confirmed by laboratory tests within 7 days prior to first dose: bone marrow function (no transfusion/growth factors within 2 weeks pre-screening): absolute neutrophil count ≥1.5×10⁹/l;platelet count ≥75×10⁹/l;hemoglobin ≥90 g/l hepatic function:total bilirubin ≤1.5×uln (≤3×uln with liver metastases); ast/alt ≤2.5×uln (≤5×uln with liver metastases);albumin ≥28 g/l renal function:serum creatinine ≤1.5×uln or creatinine clearance ≥50 ml/min. coagulation:inr and aptt ≤1.5×uln. chronic hbv-infected subjects must have hbv-dna \<1,000 iu/ml and commit to antiviral therapy throughout the study. * prior treatment-related toxicities resolved to ≤grade 1 (ctcae v5.0) or stabilized (excluding alopecia/pigmentation). * subjects of reproductive potential must use highly effective contraception from icf signing until 6 months post-last dose. * ability to communicate effectively with investigators and comply with protocol-specified follow-up. exclusion criteria: * received cytotoxic chemotherapy or chinese herbal medicines with antitumor activity within 14 days prior to the first dose. * received radiotherapy, biologic therapy (e.g., cancer vaccines, cytokines, growth factors), or other immunotherapy (excluding pd-1/pd-l1 inhibitors) within 28 days or 5 half-lives (whichever is shorter) before the first dose. note: for palliative radiotherapy (≤14 days total duration) targeting non-cns lesions, a ≥7-day washout period is required prior to the first dose. * received anti-interleukin-4 receptor alpha (il-4rα) monoclonal antibodies, anti-ige monoclonal antibodies, or other biologics within 10 weeks or 5 half-lives (whichever is longer) before the first dose. * received live/attenuated vaccines within 12 weeks prior to the first dose or plans to receive such vaccines during the study. * history of hypersensitivity to anti-il-4rα monoclonal antibodies, stapokibart injection, or other protein-based therapeutics (e.g., vaccines, immunoglobulins). * grade ≥3, severe, or life-threatening immune-related adverse events (iraes) during prior immunotherapy (excluding grade 3 endocrine aes manageable with replacement therapy), or unresolved grade 1-2 iraes after treatment discontinuation. * clinically significant cardiovascular/cerebrovascular diseases, including: major events (e.g., congestive heart failure, acute mi, unstable angina, stroke, tia, dvt/pe) within 6 months before the first dose. * qtcf \>480 msec. * lvef \<50% by echocardiography. * nyha class ≥2. * uncontrolled hypertension (sbp ≥160 mmhg or dbp ≥100 mmhg; rescreening permitted if controlled post-intervention). * other cardiovascular conditions deemed high-risk by investigators. * planned major surgery during the study period. * active cns metastases. note: treated brain metastases may be eligible if radiographically/ clinically stable for ≥14 days before the first dose, confirmed by repeat imaging (≥4-week interval) during screening. * uncontrolled pleural, peritoneal, or pericardial effusion (investigator-assessed). * active mycobacterium tuberculosis infection (i.e., active tuberculosis). * hcv ab-positive with detectable hcv rna. * hiv infection or positive hiv antibody test during screening. * history of other malignancies within 5 years (exceptions: cured basal/squamous cell carcinoma, cervical/breast ductal carcinoma in situ). * active autoimmune disease requiring systemic treatment (e.g., immunomodulators, corticosteroids) within 2 years. note: replacement therapy (e.g., thyroxine, insulin) is permitted. * prior organ or allogeneic hematopoietic stem cell transplantation. * pregnancy or lactation. * any condition that may confound study results, impair compliance, or jeopardize subject safety (investigator-determined).